5 ms·

A naturally attenuated strain would still be regulated. In the US, 21 USC §321(g): > (1) The term "drug" means… (B) articles intended for use in the diagnosis,

by IdoRA 7y ago

A naturally attenuated strain would still be regulated. In the US, 21 USC §321(g): > (1) The term "drug" means… (B) articles intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease in man or other animals; CBER would be the responsible center for the FDA. Other countries have analogous regulations. Could you come to market with a naturally attenuated strain? Yes. Would it take less time? Not really, because you don’t get to do an “end run around the regulations” as you put it in another comment. The logistics of making sure it works and then setting up the supply chain and quality systems are what take the most time. There are no shortcuts in medicine.

exikyut 7y ago
Alternatively, if this approach actually works, all the countries in the world that can appropriately adapt their regulations will survive, and the ones that choose not to won't. Natural selection versus bureaucracy!
- asdfasgasdgasdg 7y ago
  It's the "figure out if it actually works" part that is going to take most of the time for any potential prophylactic option for COVID-19. The bureaucratic overhead in this particular case is not going to be the inner loop.
danieltillett 7y ago
There are plenty of shortcuts in medicine. Think how you would stop this strain from being spread by individuals once it was identified. This strain will spread no matter what the FDA says. Personally I think the regulatory authorities would rapid approve it based on the epidemiology data collected in the process of finding the strain. The FDA has already shown that it can move faster than its usual glacial pace given sufficient motivation. The much more important question is when are we going to start seriously looking for such a strain?
- ajross 7y ago
  Serious question: are we not? People are sequencing these things like crazy (c.f. the nextstrain.org data). Epidemiologists are working like mad to come up with data on severity in regions all over the globe. Virologists everywhere are dropping what they're doing otherwise to work on covid. It sorta strains reason to argue that none of these people thought of looking for an attenuated strain. Isn't the simpler truth just that finding one takes a lot of ground work that's already being done, but hasn't born fruit yet?
  - buboard 7y ago
    they re probably not sequencing asymptomatic people's virus, it would require some specific expedition. it doesn't even sound hard or expensive reply to @ajross: how would they know someone is asymptomatic? afaik they are mostly testing people who have symptoms , and their contacts (who will have contracted the same , symptomatic strain) I think in germany they did antibody testing, or PCR of swabs of people who mostly no longer had a live virus infection to sequence. also, it seems the idea has merit; and i havent read about any team looking for this specific method (identify gene deletions and tracing). It certainly doesn't hurt (and doesnt cost much) to try btw sweden is doing a survey of live infections in stockholm, however i don't think that they sequence the viruses to @danieltillet: maybe post about it in reddit on r/covid19, some epidemiologists hang out there for the latest news
    - ajross 7y ago
      Are they not? That seems like a pretty obvious experiment to do. For reference: I have a family member in virology. He reports that everyone he knows is now working on covid, mostly because if they don't they can't come to work on anything. The biggest problem is finding subjects that will produce a paper of any kind. I really don't think research bandwidth is the issue here. I guess I have to repeat the question as its converse: is there any evidence that this is not happening? If it isn't, let's figure out the right people to pressure and not just discuss it on HN. And if it is, maybe we should let the experts do their work without pretending to have had their ideas for them?
buboard 7y ago
i doubt that , if this magical strain does exist, any regulation is going to stop people from just getting themselves infected
- danieltillett 7y ago
  I doubt the regulators would even try to stop it. They can move fast when they want. The process of finding any useful strain is going generate good data that it is safe anyway.
jseliger 7y ago
Robin Hanson has been covering variolation: http://www.overcomingbias.com/2020/04/variolation-test-design.html http://www.overcomingbias.com/2020/04/variolation-test-desig... and part of the issue is that the FDA is poorly equipped and set up to respond to a pandemic. One obvious solution is to cut through the bureaucracy and make emergency exceptions, but no one with political power in the US seems to know this, or understand it.
- danieltillett 7y ago
  Ultimately a decision to use or not use any attenuated strain found will be a political decision.
- mattchew 7y ago
  There's a lot of differences in risk appetite (and actual risk) from state to state. Maybe the feds could allow states to get a waiver from FDA regulations if they want to try things like variolation. This would still require someone at the federal level to stick their neck out a little, but (I think) a lot less than if they were to propose something like this as a federal policy. We've got a federal system, let's make some use of it.

by IdoRA 7y ago

exikyut 7y ago

Alternatively, if this approach actually works, all the countries in the world that can appropriately adapt their regulations will survive, and the ones that choose not to won't. Natural selection versus bureaucracy!

asdfasgasdgasdg 7y ago
It's the "figure out if it actually works" part that is going to take most of the time for any potential prophylactic option for COVID-19. The bureaucratic overhead in this particular case is not going to be the inner loop.

danieltillett 7y ago

There are plenty of shortcuts in medicine. Think how you would stop this strain from being spread by individuals once it was identified. This strain will spread no matter what the FDA says. Personally I think the regulatory authorities would rapid approve it based on the epidemiology data collected in the process of finding the strain. The FDA has already shown that it can move faster than its usual glacial pace given sufficient motivation. The much more important question is when are we going to start seriously looking for such a strain?

ajross 7y ago
Serious question: are we not? People are sequencing these things like crazy (c.f. the nextstrain.org data). Epidemiologists are working like mad to come up with data on severity in regions all over the globe. Virologists everywhere are dropping what they're doing otherwise to work on covid. It sorta strains reason to argue that none of these people thought of looking for an attenuated strain. Isn't the simpler truth just that finding one takes a lot of ground work that's already being done, but hasn't born fruit yet?
- buboard 7y ago
  they re probably not sequencing asymptomatic people's virus, it would require some specific expedition. it doesn't even sound hard or expensive reply to @ajross: how would they know someone is asymptomatic? afaik they are mostly testing people who have symptoms , and their contacts (who will have contracted the same , symptomatic strain) I think in germany they did antibody testing, or PCR of swabs of people who mostly no longer had a live virus infection to sequence. also, it seems the idea has merit; and i havent read about any team looking for this specific method (identify gene deletions and tracing). It certainly doesn't hurt (and doesnt cost much) to try btw sweden is doing a survey of live infections in stockholm, however i don't think that they sequence the viruses to @danieltillet: maybe post about it in reddit on r/covid19, some epidemiologists hang out there for the latest news
  - ajross 7y ago
    Are they not? That seems like a pretty obvious experiment to do. For reference: I have a family member in virology. He reports that everyone he knows is now working on covid, mostly because if they don't they can't come to work on anything. The biggest problem is finding subjects that will produce a paper of any kind. I really don't think research bandwidth is the issue here. I guess I have to repeat the question as its converse: is there any evidence that this is not happening? If it isn't, let's figure out the right people to pressure and not just discuss it on HN. And if it is, maybe we should let the experts do their work without pretending to have had their ideas for them?

buboard 7y ago

i doubt that , if this magical strain does exist, any regulation is going to stop people from just getting themselves infected

danieltillett 7y ago
I doubt the regulators would even try to stop it. They can move fast when they want. The process of finding any useful strain is going generate good data that it is safe anyway.

jseliger 7y ago

Robin Hanson has been covering variolation: http://www.overcomingbias.com/2020/04/variolation-test-design.html http://www.overcomingbias.com/2020/04/variolation-test-desig... and part of the issue is that the FDA is poorly equipped and set up to respond to a pandemic. One obvious solution is to cut through the bureaucracy and make emergency exceptions, but no one with political power in the US seems to know this, or understand it.

danieltillett 7y ago
Ultimately a decision to use or not use any attenuated strain found will be a political decision.
mattchew 7y ago
There's a lot of differences in risk appetite (and actual risk) from state to state. Maybe the feds could allow states to get a waiver from FDA regulations if they want to try things like variolation. This would still require someone at the federal level to stick their neck out a little, but (I think) a lot less than if they were to propose something like this as a federal policy. We've got a federal system, let's make some use of it.